A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.

Phase 2

Recruiting

• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Interventions: Drug: Buloxibutid; Drug: Placebo

• Registration Number: NCT06588686
• Lead Sponsor: Vicore Pharma AB

Brief Summary

The ASPIRE trial is a 52 week randomized, double-blind, placebo-controlled, parallel-group, multicenter trial in which the efficacy, safety, and pharmacokinetics of orally administered buloxibutid, either on top of stable IPF therapy or as monotherapy, are assessed in participants with IPF.

Trial website: www.aspire-ipf.com

Detailed Description

Buloxibutid is an oral angiotensin II type 2 (AT2) receptor agonist and has been shown to improve lung function in IPF over 36 weeks.

Buloxibutid agonizes the AT2 receptor on alveolar epithelial type 2 cells (AEC2s), which are believed to play a central role in the disease. Buloxibutid has been demonstrated preclinically to improve AEC2 viability, alveolar integrity via surfactant secretion and epithelial repair via replenishment of gas exchange alveolar epithelial type 1 cells (AEC1s). This leads to decreasing downstream profibrotic signaling, enhancing resolution of existing fibrotic tissue via upregulation of collagenase matrix metalloproteinases, and addressing vascular disfunction associated with the disease.

The trial will include participants who are on stable licensed IPF therapy or who are currently not treated with a licensed IPF therapy. The latter group will include participants intolerant or not responsive to licensed IPF therapies, participants ineligible to receive these therapies, and participants who have voluntarily declined to receive a licensed IPF therapy after being fully informed of the potential benefits and risks of such therapy. Due to the potential risk of drug-drug interactions (DDIs), concomitant treatment with pirfenidone is not allowed in this trial. Participants who are not on antifibrotic therapy at study start may initiate such treatment during the study.

The trial is planned to enroll 270 participants, 90 participants on oral buloxibutid 100 mg BID, 90 participants on oral buloxibutid 50 mg BID, and 90 participants on oral placebo BID for 52 weeks. The treatment will be blinded and treatment allocation will be randomized.

The primary measurement will be based on spirometry, measuring the forced vital capacity (FVC).

The trial consists of 3 consecutive periods: a screening period of up to 6 weeks, a 52-week treatment period, and a follow-up period of 2-4 weeks after the 52-week visit. The study procedures have been planned with focus on optimizing patient convenience while allowing a safe conduct and strict scientific rigor.

Trial website: www.aspire-ipf.com

Study Timeline

• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Study Start: 2024-12-09
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-24
• Primary Completion: 2027-02
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buloxibutid 100 mg BID	Buloxibutid	For 52 weeks.
Buloxibutid 50 mg BID	Buloxibutid	For 52 weeks.
Placebo BID	Placebo	For 52 weeks.

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of buloxibutid compared to placebo in participants with IPF as assessed by FVC	week 52	• Absolute change from baseline in FVC (mL) at week 52

Secondary Outcome Measures

Name	Time	Method
To further evaluate the effects of buloxibutid on disease progression, respiratory-related hospitalization or death compared to placebo in participants with IPF	week 52	• A composite of the proportion of patients with an absolute FVC percent predicted (FVCpp) decrease from baseline of ≥10%; a respiratory-related hospitalization, or death, up to week 52

Trial Locations

Locations (102)

UAB Hospital, School of Medicine/Lung Health Center; 🇺🇸 Birmingham, Alabama, United States

Keck Medicine of University of Southern California; 🇺🇸 Los Angeles, California, United States

Paradigm Clinical Research Centers, Inc.; 🇺🇸 Redding, California, United States

UC Davis Health System; 🇺🇸 Sacramento, California, United States

UC San Diego Medical Center - Hillcrest; 🇺🇸 San Diego, California, United States

Paradigm Clinical Research; 🇺🇸 San Diego, California, United States

National Jewish Medical and Research Center; 🇺🇸 Denver, Colorado, United States

University of Florida Health (UF Health); 🇺🇸 Gainesville, Florida, United States

Clinical Research Specialists; 🇺🇸 Kissimmee, Florida, United States

Emory Saint Joseph's Hospital; 🇺🇸 Atlanta, Georgia, United States

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